MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL

Model Number M00542251

Device Problems Break (1069); Positioning Failure (1158); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the first band could not be deployed even after several times of attempted deployment.Reportedly, the physician retrieved the device and it was noted that the trip wire was entangled to the white band.The procedure was completed with another speedband superview super 7 device.It was also noted that there was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient condition following the procedure was stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code 2610 captures the reportable event of bands failed to deploy.Device code 1069 captures the reportable event of tripwire broken.Block h10: investigation results.The returned speedband superview super 7 device was analyzed, and a visual evaluation noted only the ligator head was returned for analysis.There were six bands attached on the ligator head and these bands presented some damage bites on them most likely caused by the suture during attempted deployment.It was also observed that one of the bands had overlapped other bands.The suture hole did not have any visual damage and the suture was returned cut.Further analysis noted that the evidence of suture cut was likely to remove the device from the scope.This condition is not considered as an issue of the device.It was also observed that the ligator head teeth were bent, indicating evidence of tension caused by the suture.No other issues with the device were noted.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity and could have contributed to the reported issues.The reported event was confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the first band could not be deployed even after several times of attempted deployment.Reportedly, the physician retrieved the device and it was noted that the trip wire was entangled to the white band.The procedure was completed with another speedband superview super 7 device.It was also noted that there was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient condition following the procedure was stable.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10395676
• MDR Text Key: 202559338
• Report Number: 3005099803-2020-03290
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0024674038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1